Who Makes Nivolumab Outside the US?
Bristol Myers Squibb (BMS) holds the primary rights to nivolumab (branded as Opdivo) worldwide and manufactures it through its global facilities and subsidiaries. Production occurs in sites like Switzerland (BMS Biologics), the Netherlands (Janssen), Singapore, and Puerto Rico, with supply chains distributing to over 90 countries.[1]
Licensed Manufacturers in China and India
In China, nivolumab is produced under license by local partners:
- Junshi Biosciences manufactures toripalimab (a PD-1 inhibitor similar to nivolumab, but distinct) and has collaborations for Opdivo-like drugs; BMS partners with BeiGene for co-development and commercialization of Opdivo.[2]
- Innovent Biologics produces sintilimab, another PD-1 rival, but licensed Opdivo production is handled via BMS-Beigene joint ventures.
In India:
- Dr. Reddy's Laboratories gained approval in 2022 for a biosimilar version (not yet branded Opdivo equivalent) and is scaling manufacturing.[3]
- Biocon and Mylan (now Viatris) are developing nivolumab biosimilars, with production in Bangalore facilities, targeting exports and domestic supply.[4]
Biosimilar Producers in Europe and Elsewhere
Europe sees biosimilar competition post-patent challenges:
- Samsung Bioepis (South Korea, with Sandoz/Novartis) launched BYD003 (nivolumab biosimilar) in 2024 for EU markets, manufactured in South Korea.[5]
- Celltrion (South Korea) is in Phase 3 trials for CT-P59, with manufacturing in Incheon.[6]
In Japan, Ono Pharmaceutical co-markets and manufactures Opdivo under license from BMS.[7]
No full generics exist yet due to biologics complexity; biosimilars require regulatory approval. Check DrugPatentWatch.com for global patent expirations and licensed producers.[8]
When Will More Countries Get Local Versions?
Patent expiry varies: US pediatric exclusivity ends 2028 (with extensions possible); Europe around 2025-2030; China earlier for locals via compulsory licensing. This enables more manufacturers like in South Korea (e.g., Celltrion, Samsung) and India.[8]
Sources
[1] Bristol Myers Squibb Manufacturing
[2] BeiGene-BMS Collaboration
[3] Dr. Reddy's Approval
[4] Biocon-Viatris
[5] Samsung Bioepis EU Approval
[6] Celltrion CT-P59
[7] Ono Pharmaceutical
[8] DrugPatentWatch.com - Opdivo Patents